In order to obtain further insight as to how NVP affects HDL metabolism, the in vivo kinetics of the HDL apolipoprotein, Apo A-1, before and 6 weeks after initiation of NVP containing treatment were evaluated. In addition, the activity of the key enzymes related to HDL metabolism were assessed.

[ Designated as safety issue: No ]

In order to determine the relevance of the HDL increase in decreasing cardiovascular risk in HIV-positive subjects we evaluated endothelial function (FMD) as a surrogate marker for cardiovascular disease in patients.

An Open-label, Non-randomized, Single-arm Study, to Investigate the Mechanism(s) by Which Nevirapine Increases Plasma High Density Lipoproteins Concentration in HIV+ Subjects Treated With VIRAMUNE® Tablets

Percentage change in the proteins involved in HDL metabolism [ Time Frame: after 6 and 24 weeks of treatment ] [ Designated as safety issue: No ]

The percentage change in plasma levels of lipoproteins in the fasting lipid panel (TC, LDL, HDL, TG) from Week 0 (baseline) to 6 and 24 weeks of treatment with NVP-based antiretroviral therapy [ Time Frame: from week 0 to 6, and 24 weeks of treatment ] [ Designated as safety issue: No ]

The percentage change in activity (and/or mass) of the constituents of the lipid enzymes panel from Week 0 to 24 weeks of NVP-based antiretroviral therapy [ Time Frame: from week 0 to 24 weeks of treatment ] [ Designated as safety issue: No ]

Ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Patients on stable therapy with Trizivir only (or its equivalent component drugs), for at least 6 months prior to screening.

Patients with plasma HIV-1-RNA <=50 copies/mL documented on at least two occasions within 6 months prior to enrollment.

Documentation of plasma HIV-1 RNA of <=50 copies/mL for >=6 months while on Trizivir without other antiretroviral agent. Documentation will include dates and results of all viral load testing from the previous six months.

Ability and willingness to complete the study.

Exclusion Criteria:

Patients will not be included when they meet one or more of the following criteria:

Hepatic, renal or thyroid abnormalities, as determined significant by the Principal Investigator.

Pregnancy or lactation.

Active anticoagulation therapy (coumarin derivates, heparin).

History of HIV-2 infection.

Female patients with CD4 counts >250 cells/mm3.

Male patients with CD4 counts >400 cells/mm3. Others which can not be listed here.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144261